無(wú)創(chuàng)通氣在雙胞胎早產(chǎn)兒新生兒呼吸窘迫綜合征中的隨機(jī)對(duì)照研究
發(fā)布時(shí)間:2018-08-16 07:43
【摘要】:目的無(wú)創(chuàng)通氣中最常見的兩種通氣方式--經(jīng)鼻持續(xù)正壓通氣和經(jīng)鼻間歇正壓通氣已經(jīng)被證明是一種對(duì)早產(chǎn)兒新生兒呼吸窘迫綜合征非常有效的治療策略,總體有效率在60%以上;在臨床工作中,哪一種方式更加有利于減少新生兒氣管插管、減少新生兒后遺癥和并發(fā)癥,目前國(guó)際上對(duì)此還是沒有統(tǒng)一的認(rèn)識(shí)。由于國(guó)內(nèi)外的類似研究在基本臨床資料特征、特別是母孕期疾病定性和定量平衡上存在一定的差異性(如母孕期血糖8mmol/l和15mmol/l均定性為“高”,在統(tǒng)計(jì)分析時(shí)定義為具有同質(zhì)性;實(shí)際上,這兩個(gè)血糖值對(duì)早產(chǎn)兒的各個(gè)器官發(fā)育的影響是不一致的,因此可能潛在影響主要臨床結(jié)局和次要臨床結(jié)局,在統(tǒng)計(jì)學(xué)上具有非同質(zhì)性),我們推測(cè)這些差異性可能在其中扮演了重要的作用。因此,本研究的目的是在既往定性平衡研究的基礎(chǔ)上,完全去除母孕期疾病的影響后,評(píng)價(jià)兩種通氣方式對(duì)插管率和后遺癥、并發(fā)癥的影響。方法我們?cè)?011年1月至2014年7月實(shí)施了一項(xiàng)單中心的臨床隨機(jī)對(duì)照研究,本研究主要針對(duì)雙胞胎早產(chǎn)兒,這些早產(chǎn)兒被診斷為新生兒呼吸窘迫綜合征。在這對(duì)雙胞胎中,一個(gè)早產(chǎn)兒隨機(jī)給予經(jīng)鼻持續(xù)正壓通氣,另一個(gè)給予經(jīng)鼻間歇正壓通氣。在這些早產(chǎn)兒被明確診斷新生兒呼吸窘迫綜合征的情況下,肺泡表面活性物質(zhì)作為一種搶救性治療手段,與家屬協(xié)商并取得家屬同意后予以氣管內(nèi)滴入。本研究的主要結(jié)局指標(biāo)為在100天內(nèi)的氣管插管率;次要結(jié)局指標(biāo)則包括早產(chǎn)兒的相關(guān)并發(fā)癥,如支氣管肺發(fā)育不良,早產(chǎn)兒視網(wǎng)膜病變,顱內(nèi)出血,新生兒敗血癥,肺泡表面活性物質(zhì)的管理次數(shù)和劑量,新生兒壞死性小腸結(jié)腸炎,動(dòng)脈導(dǎo)管未閉,以及無(wú)創(chuàng)通氣的不良反應(yīng)等等。結(jié)果143對(duì)被診斷為新生兒呼吸窘迫綜合征的早產(chǎn)兒被納入本研究,其中129對(duì)最終完成了本研究隨訪。與經(jīng)鼻持續(xù)正壓通氣相比較,經(jīng)鼻間歇正壓通氣并沒有明顯減少氣管插管率(11.9%vs 19.6%,P=0.080);考慮到早產(chǎn)兒新生兒呼吸窘迫綜合征和胎齡大小存在明顯的負(fù)性相關(guān),為了避免胎齡差異性過(guò)大引起結(jié)果解釋的不一致,我們根據(jù)胎齡設(shè)置了亞組。在亞組分析中,也沒有表現(xiàn)出來(lái)明顯的統(tǒng)計(jì)學(xué)差異(11.1%vs19.7%,P=0.087)。與此同時(shí),也考慮到胎齡和肺泡表面活性物質(zhì)可能存在交互反應(yīng),這種交互作用可能對(duì)插管率有明顯影響,我們也做了交互分析,結(jié)果也沒有顯示這種交互作用可以影響插管率(χ2=0.234,P=0.628)。與此同時(shí),在次要結(jié)局指標(biāo)中,也沒有發(fā)現(xiàn)差異性存在統(tǒng)計(jì)學(xué)意義。結(jié)論在本次雙胞胎中進(jìn)行的隨機(jī)對(duì)照研究中,我們完全消除了母親孕期疾病對(duì)新生兒的影響。結(jié)果顯示,與經(jīng)鼻持續(xù)正壓通氣相比較,經(jīng)鼻間歇正壓通氣并沒有顯著性降低早產(chǎn)兒患新生兒呼吸窘迫綜合征時(shí)的氣管插管率。我們的結(jié)果暗示,在類似的既往研究中,母親孕期疾病定性平衡的不一致可能是導(dǎo)致目前國(guó)際上存在這種差異的重要原因之一。
[Abstract]:Objective The two most common modes of noninvasive ventilation, transnasal continuous positive pressure ventilation and transnasal intermittent positive pressure ventilation, have been proved to be very effective in the treatment of neonatal respiratory distress syndrome in premature infants with an overall efficiency of more than 60%; which is more conducive to reducing neonatal tracheal intubation in clinical work There is still no international consensus on this issue. Similar studies at home and abroad, especially on the qualitative and quantitative balance of maternal and pregnant diseases, have some differences (such as maternal blood glucose 8 mmol/l and 15 mmol/l are both "high" in statistical analysis. Defined as homogeneity; in fact, the effects of these two blood glucose values on the development of various organs in premature infants are inconsistent, and therefore may potentially affect major clinical outcomes and secondary clinical outcomes, which are statistically heterogeneous. We speculate that these differences may play an important role in this study. Methods From January 2011 to July 2014, we conducted a single-center randomized controlled clinical study on twin preterm infants who were treated with two different ventilation methods. In these twins, one premature infant was randomly given continuous positive nasal pressure ventilation and the other was given intermittent positive nasal pressure ventilation. The primary outcome measure was the intubation rate within 100 days. Secondary outcome measures included complications associated with premature infants, such as bronchopulmonary dysplasia, retinopathy, intracranial hemorrhage, neonatal sepsis, and management of alveolar surfactant. Results 143 pairs of premature infants diagnosed with neonatal respiratory distress syndrome were included in the study. 129 pairs of them were eventually followed up. Compared with continuous positive nasal pressure ventilation, intermittent positive nasal pressure ventilation was performed. There was no significant reduction in intubation rate (11.9% vs 19.6%, P = 0.080); considering the significant negative correlation between neonatal respiratory distress syndrome and gestational age, we set up subgroups according to gestational age in order to avoid inconsistent interpretation of the results caused by excessive gestational age differences. At the same time, considering the possible interaction between gestational age and alveolar surfactant, which may have a significant effect on intubation rate, we also made an interactive analysis, and the results did not show that this interaction can affect the intubation rate (2 = 0.234, P = 0.628). At the same time, in the second time, in the second time Conclusion In this randomized controlled study of twins, we completely eliminated the effects of maternal illness during pregnancy on newborns. The results showed that nasal intermittent positive pressure ventilation did not significantly reduce the incidence of neonatal premature infants compared with nasal continuous positive pressure ventilation. Our results suggest that inconsistencies in the qualitative balance of maternal illness during pregnancy may be one of the important reasons for this difference internationally.
【學(xué)位授予單位】:第三軍醫(yī)大學(xué)
【學(xué)位級(jí)別】:博士
【學(xué)位授予年份】:2016
【分類號(hào)】:R722.6
[Abstract]:Objective The two most common modes of noninvasive ventilation, transnasal continuous positive pressure ventilation and transnasal intermittent positive pressure ventilation, have been proved to be very effective in the treatment of neonatal respiratory distress syndrome in premature infants with an overall efficiency of more than 60%; which is more conducive to reducing neonatal tracheal intubation in clinical work There is still no international consensus on this issue. Similar studies at home and abroad, especially on the qualitative and quantitative balance of maternal and pregnant diseases, have some differences (such as maternal blood glucose 8 mmol/l and 15 mmol/l are both "high" in statistical analysis. Defined as homogeneity; in fact, the effects of these two blood glucose values on the development of various organs in premature infants are inconsistent, and therefore may potentially affect major clinical outcomes and secondary clinical outcomes, which are statistically heterogeneous. We speculate that these differences may play an important role in this study. Methods From January 2011 to July 2014, we conducted a single-center randomized controlled clinical study on twin preterm infants who were treated with two different ventilation methods. In these twins, one premature infant was randomly given continuous positive nasal pressure ventilation and the other was given intermittent positive nasal pressure ventilation. The primary outcome measure was the intubation rate within 100 days. Secondary outcome measures included complications associated with premature infants, such as bronchopulmonary dysplasia, retinopathy, intracranial hemorrhage, neonatal sepsis, and management of alveolar surfactant. Results 143 pairs of premature infants diagnosed with neonatal respiratory distress syndrome were included in the study. 129 pairs of them were eventually followed up. Compared with continuous positive nasal pressure ventilation, intermittent positive nasal pressure ventilation was performed. There was no significant reduction in intubation rate (11.9% vs 19.6%, P = 0.080); considering the significant negative correlation between neonatal respiratory distress syndrome and gestational age, we set up subgroups according to gestational age in order to avoid inconsistent interpretation of the results caused by excessive gestational age differences. At the same time, considering the possible interaction between gestational age and alveolar surfactant, which may have a significant effect on intubation rate, we also made an interactive analysis, and the results did not show that this interaction can affect the intubation rate (2 = 0.234, P = 0.628). At the same time, in the second time, in the second time Conclusion In this randomized controlled study of twins, we completely eliminated the effects of maternal illness during pregnancy on newborns. The results showed that nasal intermittent positive pressure ventilation did not significantly reduce the incidence of neonatal premature infants compared with nasal continuous positive pressure ventilation. Our results suggest that inconsistencies in the qualitative balance of maternal illness during pregnancy may be one of the important reasons for this difference internationally.
【學(xué)位授予單位】:第三軍醫(yī)大學(xué)
【學(xué)位級(jí)別】:博士
【學(xué)位授予年份】:2016
【分類號(hào)】:R722.6
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1 楊小剛;盧院華;楊春麗;;無(wú)創(chuàng)通氣在急性呼吸窘迫綜合征早期中的應(yīng)用[J];江西醫(yī)藥;2013年09期
2 曹域,胡征;無(wú)創(chuàng)通氣在早期急性呼吸窘迫綜合征治療中的作用[J];中國(guó)誤診學(xué)雜志;2001年08期
3 張y暯,
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